Diabetic FootNCT02233179
The Association Between Unprotected Standing, Walking and Wound Healing in Diabetes
A study testing Removable cast walker and Irremovable cast walker in people with Diabetic Foot, run by University of Arizona at 1 site in United States.
Trial summary
The aim of the study was to explore the association between activities of daily living ( measured using a body-worn sensor) on wound healing in diabetic patients. Since this was an exploratory study, there was no study hypothesis. Read more about this study
- Who is it for?
- Ages 37 to 68 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Removable cast walker and Irremovable cast walker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 or older with non-infected, non-ischemic foot ulcers
- active neuropathic foot ulcer
Who cannot join
- major foot amputation
- active Charcot arthropathy
- ankle brachial index of 0.5 or less
- history of substance abuse within 6 months
- inability to walk 20m
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Body-worn Sensor Technology for Improving Diabetic Care During Activities of Daily Living
The aim of the study was to explore the association between activities of daily living ( measured using a body-worn sensor) on wound healing in diabetic patients. Since this was an exploratory study, there was no study hypothesis.
Read the detailed description
Diabetes patients with active foot ulcers were recruited and monitored for activities of daily living while wearing an offloading device.
- Conditions
- Diabetic Foot
- Being tested
- Removable cast walker, Irremovable cast walker
- Keywords
- Diabetic foot ulcer
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removable cast walkerDevice
Also called Cast walker from Ossur, Reykjavik, Iceland
Offloading device that can be removed by patients.
Irremovable cast walkerDevice
Also called Cast walker from Ossur, Reykjavik, Iceland
Offloading device that cannot be removed by patients.
| Study group | Role | What they receive |
|---|---|---|
| Removable Cast Walker | Experimental | An offloading device that can be removed by the patients Receives: Device: Removable cast walker |
| Irremovable Cast Walker | Active comparator | A removable cast rendered irremovable using instant total contact cast, so patients cannot remove offloading device. Receives: Device: Irremovable cast walker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound size
Wound size was measured every week for 12 weeks
Measured: 12 weeks
Daily Physical Activities
Recorded using a body-worn sensor and measured every 4 weeks for 2 days.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startJun 2009
- Primary completionAug 2011
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Qatar National Research Fund
- Responsible party
- Sponsor
- Investigators
- David G Armstrong, DPM, MD, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233179
- Sponsor's protocol ID
- 0900000701
- Status last verified
- Sep 2014
- First submitted
- 8 Aug 2014
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body-worn Sensor Technology for Improving Diabetic Care During Activities of Daily Living
- ClinicalTrials.gov ID
- NCT02233179
- Acronym / sponsor ID
- 0900000701
- Conditions
- Diabetic Foot
- Keywords
- Diabetic foot ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Qatar National Research Fund
- Study start
- Jun 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study was to explore the association between activities of daily living ( measured using a body-worn sensor) on wound healing in diabetic patients. Since this was an exploratory study, there was no study hypothesis.
Detailed description
Diabetes patients with active foot ulcers were recruited and monitored for activities of daily living while wearing an offloading device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Removable Cast Walker | Experimental | Device: Removable cast walkerAn offloading device that can be removed by the patients |
| Irremovable Cast Walker | Active comparator | Device: Irremovable cast walkerA removable cast rendered irremovable using instant total contact cast, so patients cannot remove offloading device. |
Who may qualify
- Ages
- 37 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18 or older with non-infected, non-ischemic foot ulcers
- active neuropathic foot ulcer
Key exclusion criteria (5 listed)
- major foot amputation
- active Charcot arthropathy
- ankle brachial index of 0.5 or less
- history of substance abuse within 6 months
- inability to walk 20m
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Removable cast walkerAlso: Cast walker from Ossur, Reykjavik, IcelandOffloading device that can be removed by patients. | Device | Removable Cast Walker |
| Irremovable cast walkerAlso: Cast walker from Ossur, Reykjavik, IcelandOffloading device that cannot be removed by patients. | Device | Irremovable Cast Walker |
Primary outcome
Wound size
Time frame: 12 weeks
Wound size was measured every week for 12 weeks
Daily Physical Activities
Time frame: 12 weeks
Recorded using a body-worn sensor and measured every 4 weeks for 2 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David G Armstrong, DPM, MD, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Removable cast walker and Irremovable cast walker in people with Diabetic Foot, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound size (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2014.